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FDA Approves Non-Hormonal Drug For Hot Flashes During Menopause

The Unites States Food and Drugs Administration has approved the first non-hormonal drug to treat hot flashes associated with menopause. The U.S. Food and Drugs Administration has approved the first non-hormonal drug to treat hot flashes associated with menopause. The drug, Brisdelle ( paroxetine ), contains the selective serotonin reuptake inhibitor paroxetine mesylate and can be used to treat moderate to severe hot flashes experience by women during menopause. Hot flashes during menopause are known to affect 75 percent of women worldwide. According to a FDA press release , though this condition is not fatal it can carry on for five or more years in some women causing a lot of discomfort and disrupted sleep. "There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments," said Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive and Urologic Products in the F...

FDA approves over-the-counter sales for Plan B

Women and girls age 15 and over will soon be able to buy emergency contraception without a prescription. The Food and Drug Administration announced on Tuesday that it was approving Plan B One-Step, also known as the morning-after pill, to be sold in the retail aisle next to other over-the-counter medications. Customers will not have to ask a pharmacist for it. FDA officials say the announcement is unrelated to a federal judge's order earlier this month, which gave the agency 30 days to make the pill available to all girls and women without a prescription, regardless of age. Until now, women have had to ask a pharmacist for emergency contraception. Those under 17 could get the pill only with a prescription. In his April 5th ruling,U.S. District Court Judge Edward Korman noted that emergency contraception has been shown to be extremely safe, and that the FDA's age limits were arbitrary. "FDA has engaged in intolerable delays," Korman said, amounting to an "adm...